A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumours

Official Title

A Phase 2, Multicentre, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumours (DESTINY-PanTumour02)

Summary:

This is an open-label, multi-centre, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumours. This study will enroll 7 tumour-specific cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumours. Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favourable risk benefit profile in selected HER2-expressing solid tumours.

Trial Description

Primary Outcome:

  • Objective Response Rate (ORR)
Secondary Outcome:
  • Duration of response (DoR)
  • Disease control rate (DCR)
  • Progression free survival (PFS)
  • Proportion of patients alive and progression-free at 6 months and 12 months
  • Overall survival (OS)
  • Proportion of patients alive at 6 and 12 months
  • Occurrence of adverse events (AEs) and serious adverse events (SAEs)
  • Pharmacokinetics (PK) assessed by serum concentration of T-DXd, total anti-HER2 antibody and MAAA-1181
  • The immunogenicity of T-DXd assessed by the presence of ADAs for T-DXd

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society